Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of kpi-121 in subjects with postsurgical inflammation and pain

Conditions: Post Surgical Ocular Inflammation and Pain

Summary: the primary objective of the study is to investigate the efficacy and safety of kpi-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

this is a phase iii, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of kpi-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Eligibility criteria:
inclusion criteria: candidates for routine, uncomplicated cataract surgery in investigator's opinion, potential postoperative snellen distance va by pinhole method of at least 20/200 in study eye. exclusion criteria: * known hypersensitivity/contraindication to study product(s) or components. * history of glaucoma, intraocular pressure (iop) \>21 mmhg at the screening or randomization visits, or being treated for glaucoma in either eye. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery. * in the opinion of investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Keywords: postsurgical postoperative ocular cataract inflammation pain corticosteroid
to investigate the effects of azd1981 on the qt interval

Conditions: Asthma

Summary: the purpose of this research study is to evaluate the effect of azd1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. the effect of azd1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. the investigators will also compare the effects of azd1981 with a "dummy drug" (placebo). the investigators will also be evaluating how safe and well tolerated azd1981 is and how much azd1981 enters the blood circulation by collecting blood during the study.


Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18 to 55 years (inclusive) * subjects must be willing to use barrier methods of contraception during study and for 3 months after last dosing. * be a non-smoker or ex-smoker who has stopped smoking for \>6 months exclusion criteria: * any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) * history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, personal or family history of arrhythmia or long qt syndrome)
effects of chocolate in patients with chronic heart failure

Conditions: Heart Failure

Summary: the aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (nestlé placebo chocolate) on top of standard medication. moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as c-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.


Eligibility criteria:
inclusion criteria: 1. heart failure ( nyha ≥ii, lvef\<50%, independent of aetiology) 2. nonsmokers 3. age: 30-80 4. written obtained informed consent exclusion criteria: 1. decompensated heart failure 2. instable angina pectoris 3. smokers 4. ventricular tachyarrhythmias or av-block \>i° 5. renal failure (\>200 umol) 6. liver disease (alt or ast \>150 iu) 7. diabetes mellitus 8. obesity (bmi \>30 kg/m2) 9. symptomatic hypotension, hypertension \>160/100mmhg 10. known allergy to compounds of nestlé noir intense 11. history of gastric ulcer or bleeding, current diarrhea 12. venous thrombosis or pulmonary embolism, at present or recurrent history of infectious disease, acutely or chronic 13. disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) 14. neoplasia (unless healed or remission \>5 years) 15. participation in another study within the last month 16. concomitant vitamin supplements

Keywords: chocolate, heart failure, endothelial function, platelet adhesion, oxidative stress, baroreceptor function,
dehydroepiandrosterone substitution in adolescent and young women with central adrenal insufficiency

Conditions: Adrenal Insufficiency

Summary: 30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of dhea are recruit. the clinical trial is double-blind to show that the substitution of the hormone dhea stimulates secondary hair growth, enhances well being and mood of the patients. it should also normalize the serum content of dhea, aldosterone and testosterone.

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of dhea are recruit. after randomization they either get dhea or placebo for 12 months daily. the clinical trial is double-blind to show that the substitution of the hormone dhea stimulates secondary hair growth, enhances well being and mood of the patients. it should also normalize the serum content of dhea, aldosterone and testosterone.

Eligibility criteria:
inclusion criteria: * female gender * age between 13 and 26 years * breast developement minimal tanner stage 3 * serum content of dheas less than 400 ng/ml * central hypocortisolism * 2 additional pituitary hormon deficiencies (growth hormone, tsh, fsh, lh, prolactin, adh) * no scheduled change of the auxilliary medication during the clinical trial exclusion criteria: * initial diagnosis of a cerebral tumor less than one year * constitution after cerebral exposure with over 30 gray * craniopharyngioma with hypothalamic defect syndrome or relapse * blindness * mental retardation or psychiatric disorder * systemic disorder, diabetes mellitus, cardiovascular disease, liver disease requiring treatment * elevated liver enzyme levels * pregnancy * in case of no hypogonadism: no secure contraception

Keywords: central adrenal insufficiency dhea pubes
evaluation of the watchman left atrial appendage (laa) closure device in patients with atrial fibrillation versus long term warfarin therapy

Conditions: Atrial Fibrillation; Stroke

Summary: this was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the watchman laa closure technology. the purpose of the prevail study was to confirm the efficacy endpoint as demonstrated in the protect af pivotal study and to further demonstrate that the watchman laa closure technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.


Eligibility criteria:
key inclusion criteria: * paroxysmal, persistent or permanent non-valvular af * eligible for long-term warfarin therapy * eligible to come off warfarin therapy * calculated chads2 score of 2 or greater. also patients with a chads2 score of 1 may be included if any of the following apply: * female age 75 or older * baseline lvef ≥ 30 and \< 35% * aged 65-74 and has diabetes or coronary artery disease * aged 65 or greater and has congestive heart failure key exclusion criteria: * contraindicated/allergic to aspirin * indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment * history of atrial septal repair or has an asd/pfo device * implanted mechanical valve prosthesis * nyha class iv chf * resting heart rate \> 110 bpm * participated previously in the protect af or cap registry studies key echo exclusion criteria: * lvef \< 30% * existing pericardial effusion \> 2mm * high risk pfo * significant mitral valve stenosis * complex atheroma with mobile plaque of the descending aorta and/or aortic arch * cardiac tumor

Keywords: atrial fibrillation stroke tia trans ischemic attack warfarin coumadin
optimization strategy for the prevention of ams by ripc combined with acetazolamide

Conditions: Acute Mountain Sickness

Summary: the primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (ripc) combined with acetazolamide can further reduce the incidence of acute mountain sickness (ams) during the 6-hour hypoxic chamber.

the current measures to prevent acute mountain sickness (ams) mainly include drug prevention and non-drug prevention. acetazolamide is a drug approved by the u.s. fda for the prevention and treatment of ams. remote limb ischemic preconditioning (ripc) can also reduce the incidence of ams as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of ams in 6 hours from 40% to 30%. the objective of this study is to determine whether rapid ripc training combined with acetazolamide can further reduce the incidence of ams. in this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), ripc group (ripc training twice daily, 6 days before entering the hypoxic room), rapid ripc group (ripc training forth daily, 3 days before entering the hypoxic room), combined group (rapid ripc training plus acetazolamide) and controlled group. ripc training, completed by renqiao remote ischemic conditioning device (doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmhg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. after the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. the incidence of ams and other data will be compared between groups.

Eligibility criteria:
inclusion criteria: * people who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days; * sign the informed consent form voluntarily. exclusion criteria: * chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.; * the female is pregnant or in the period of preparing for pregnancy or breast-feeding; * have a history of smoking; * have a history of thrombosis in the upper limbs; * severe damage to local soft tissues of upper limbs, fractures, etc.; * allergic to sulfa; * are taking one or more drugs; * past laboratory tests suggest hypokalemia, hyponatremia, or liver and kidney damage; * patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Keywords: acute mountain sickness acetazolamide remote ischemic preconditioning
study of a nutritional supplement for healthy aging

Conditions: Nutrition, Healthy; Quality of Life

Summary: the main aim of this clinical trial is to learn if a nutritional supplement improves health status from a nutritional point of view in an active and healthy elderly population. it will also study about the improvement of anthropometric variables, vitality, quality of life and mood, as well as biochemical and metabolic changes produced after the intervention. the main questions it aims to answer are: * does a nutritional supplement improve the general nutritional status? * what health parameters improve most clearly after taking the supplement? researchers will compare a nutritional supplement to a placebo (a look-alike substance that contains no interest nutrients) to see if the nutritional supplement works to improve health status from a nutritional point of view. participants will: * take a nutritional supplement or a placebo every day for 8 weeks. * visit the clinic once every 4 weeks for checkups and tests * keep a diary of their symptoms and the degree of adherence to taking the nutritional supplement.


Eligibility criteria:
inclusion criteria: * men and women between 65 and 80 years of age, inclusive. * body mass index (bmi) less than 35 kg/m2. * subjects must have a cultural level, general physical and psychological conditions that allow the understanding, monitoring and development of the study. * agree to voluntarily participate in the study and provide their informed consent in writing, complying with the procedures and requirements of the study. exclusion criteria: * people allergic to soy or lactose, as the supplement contains traces. * severe diseases or relevant functional or structural abnormalities of the digestive system: inflammatory bowel disease. * surgical interventions of the digestive system with permanent sequelae such as resections (gastroduodenostomy...) * presenting any type of serious or chronic or systemic disease such as: infections that cause impairment of the general condition, cardiovascular diseases, cardiac arrhythmias, stroke, neoplasia, severe kidney disease, liver disease... * recent fracture in the last 3 months (strength training). * subjects who present some type of cognitive and/or psychological impediment, alzheimer's, depressive pathology, etc. * pharmacological treatment that affects the study variables recently prescribed, without a stable dose prescribed. * people with diabetes of any type. * intake of any type of nutritional supplement that includes vitamin d, folic acid, vitamin b6, vitamin b12, calcium, iron, zinc or proteins, in the last 3 months. * being on any type of special diet and/or high alcohol consumption (more than 14 units in women and 20 units in men per week). * subjects in whom poor collaboration is expected or who, in the opinion of the researcher, have difficulties in following the procedures of the study. * lack of commitment (in the opinion of the researcher) to the intervention, suspicion of non-compliance, or real difficulties in following the development of the study.

Keywords: healthy aging nutritional status nutritional supplement quality of life
phase 2 study of tlk286 in metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to determine the effectiveness of tlk286 in treatment of metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of breast cancer * metastatic disease * measurable or evaluable disease * no prior chemotherapy regimens * age at least 18 years * adequate liver and kidney function * adequate bone marrow function exclusion criteria: * pregnant or lactating women * unstable medical conditions * chemotherapy within 14 days of tlk286 * radiation therapy within 14 days of tlk286 * hormonal therapy within 14 days of tlk286 * immunotherapy within 14 days of tlk286 * cns metastasis unless controlled by treatment
drug risk aversion calculator use to facilitate ms patient self-efficacy

Conditions: Multiple Sclerosis

Summary: the investigators seek to determine if the use of a side effect aversion calculator helps patients with multiple sclerosis (ms) more comfortably and rapidly identify the disease modifying drug (dmd) that is best suited for the patient.

settling into the use of a multiple sclerosis disease modifying drug (dmd) can seem like taking an important final examination, consisting of a single multiple choice question with 16 equally appropriate responses, having months or even years to second-guess your choice, and then getting a grade but never being told the correct answer. making the choice between these options can be overwhelming, leaving patients feeling both disempowered and depersonalized in the decision-making process. in order to allow a better, more personalized, decision-making process the investigators introduce a side effect aversion calculator, which takes a patient's individual side effect aversion profile into consideration when discussing the start of a new disease modifier (initial drug, or drug switch). subjects will be multiple sclerosis patients who have a provider-identified need for dmd initiation or dmd switch and receive their care at duke. recruitment goal is 100 subjects. those randomized to "calculator arms" will be reminded that the purpose of the calculator is to facilitate the dmd choice discussion, not make the decision. subjects asked to rate level of concern over adverse events (aes) across all dmds. calculator multiplies subject response by the prevalence reported within dmd prescribing information. sum of these weighted scores reveals a dmd's total aversion score and medication ranking by patient's specific side effect aversion profile, therefore framing discussion. enrollment visit concludes with survey designed to collect ms clinical history, ms symptoms, medication history, medication adherence and self-efficacy. this same survey is conducted prior to subsequent three clinic visits.

Eligibility criteria:
inclusion criteria: * be at least 18 years old * be able to read and speak english * be currently treated or starting treatment with an ms disease modifying medication exclusion criteria: * all of the inclusion criteria must be met. if they cannot be met, then they are excluded from the study
expressive writing for the management of stress in cancer survivors

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. this stress can be further exacerbated by social upheavals such as the covid-19 pandemic. for safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. together with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience. the goal of this trial is to learn more about the experiences of cancer survivors during stressful times.

primary objectives: i. to evaluate the feasibility of the virtual study for cancer survivors. ii. to preliminarily assess the impact of the intervention for cancer survivors. outline: patients are randomized to 1 of 2 arms. arm i (intervention): patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) once weekly (qw) for 3 weeks. arm ii (control): patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) qw for 3 weeks.

Eligibility criteria:
inclusion criteria: * at least 18 years old * have a diagnosis of cancer within the past 3 years * are able to speak and read in english * have access to a computer or smart phone with internet connection * all disease sites and all cancer stages are eligible for enrollment exclusion criteria: * inability to provide informed consent * non-english speakers will be excluded because this is a feasibility study that will enroll only a limited number of participants
non-ablative er:yttrium aluminum garnet laser for stress urinary incontinence (sui)

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence (sui) is a common complaint in women after childbirth. the aim of this study was to evaluate the efficacy and safety of non-ablative er:yag laser therapy in the treatment of sui and improvement of sexual gratification in parous women. 114 premenopausal parous women with sui were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. both groups were treated according to the incontilasetm clinical treatment protocol for sui with non-ablative thermal-only er:yag laser, except that there was no energy output when treating the sham group. patients were blinded to the allocation. at baseline and 3 months after treatment patients were clinically examined, answered questionnaires for sui severity sexual function assessment and their pelvic floor muscle (pfm) function was assessed with perineometry. the improvement in the laser group will be compared to the improvement in the sham group.

stress urinary incontinence (sui) is a common complaint in women after childbirth. it affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. there is a need for effective non-invasive treatment alternatives. the aim of this study was to evaluate the efficacy and safety of non-ablative er:yag laser therapy in the treatment of sui and improvement of sexual gratification in parous women. 114 premenopausal parous women with sui were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. both groups were treated according to the incontilasetm clinical treatment protocol for sui with non-ablative thermal-only er:yag laser, except that there was no energy output when treating the sham group. patients were blinded to the allocation. at baseline and 3 months after treatment patients were clinically examined, answered questionnaires for sui severity sexual function assessment and their pelvic floor muscle (pfm) function was assessed with perineometry. validated international consultation on incontinence questionnaire - urinary incontinence short form (iciq-ui sf) was used as the primary outcome measure. the pelvic organ prolapse urinary incontinence sexual questionnaire short form (pisq-12) and the female sexual function index (fsfi) were used to assess the sexual function. patients were monitored for discomfort and side-effects during treatment and follow up period.

Eligibility criteria:
inclusion criteria: * diagnosis of stress urinary incontinence * sexually active * at least one vaginal delivery exclusion criteria: * pelvic organ prolapse greater than stage i * urgency or mixed ui * infection * previous gynaecologic surgery or irradiation * refuse consent

Keywords: stress urinary incontinence sexual dysfunction laser er:yag vaginal laser vaginal tightening non-ablative minimally-invasive
fenofibrate in combination with ursodeoxycholic acid in primary biliary cholangitis: a real world study

Conditions: Primary Biliary Cholangitis (PBC)

Summary: an open label long-term study to evaluate the safety and tolerability of fenofibrate in combination with ursodeoxycholic acid in subjects with primary biliary cholangitis (pbc)


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent (signed and dated) 2. completed in a pbc study with fenofibrate(nct05751967) 3. females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose exclusion criteria: 1. treatment-related adverse event (ae) leading to study drug discontinuation in a previous pbc study with seladelpar 2. a medical condition, other than pbc, that in the investigator's opinion would preclude full participation in the study or confound its results